Pediatric Chronic Myeloid Leukemia Registry (PCMLR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2011 by Poitiers University Hospital
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
University of Milano Bicocca
University Medical Centre Groningen
University Hospital of Liege
Imperial College London
University Hospital Dresden
International BFM Study Group
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01281735
First received: January 14, 2011
Last updated: February 7, 2011
Last verified: February 2011
  Purpose

The purpose of the study is to describe and characterize CML in a large pediatric cohort of patients.


Condition
Chronic Myeloid Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: INTERNATIONAL STUDY of Chronic Myeloid Leukaemia (CML) Treatment and Outcomes in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Estimated Enrollment: 750
Study Start Date: January 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients less than 18 years of age with newly diagnosed Philadelphia positive and/or bcr-abl positive CML are eligible whatever the phase of the disease, the type of treatment and the enrollment or not in a clinical study.

Criteria

Inclusion Criteria:

  • patients less than 18 years of age
  • diagnosed Philadelphia positive and/or BCR-ABL positive Chronic Myeloid Leukemia (CML) all phases

Exclusion Criteria:

  • patients more than 18 years of age at diagnosis of CML
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281735

Contacts
Contact: Frederic MILLOT, MD +33 (0)5 49 44 30 78 f.millot@chu-poitiers.fr

  Show 17 Study Locations
Sponsors and Collaborators
Poitiers University Hospital
Institut National de la Santé Et de la Recherche Médicale, France
University of Milano Bicocca
University Medical Centre Groningen
University Hospital of Liege
Imperial College London
University Hospital Dresden
International BFM Study Group
Investigators
Principal Investigator: Frederic MILLOT, MD Poitiers University Hospital
  More Information

No publications provided

Responsible Party: MILLOT, Clinical investigation center CIC 0802
ClinicalTrials.gov Identifier: NCT01281735     History of Changes
Other Study ID Numbers: CIC09-33, 2010-023359-27
Study First Received: January 14, 2011
Last Updated: February 7, 2011
Health Authority: France: French Data Protection Authority

Keywords provided by Poitiers University Hospital:
treatment outcome
side effects
Protein Kinase Inhibitors
pediatrics

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014